WHO's role in the global health system: what can be learned from global R&D debates?

Recent global debates on the research and development (R&D) of health technologies, such as drugs, diagnostics and vaccines, can be seen as a microcosm of discussions on the role of the World Health Organization (WHO) in the global health system more broadly. The global R&D system has come under heightened scrutiny with the publication of a 2012 report by the WHO Consultative Expert Working Group on Research and Development (CEWG), which made a number of recommendations to more equitably meet global health needs. The CEWG report followed a decade-long process of debate at the WHO on the weaknesses of the global R&D system, which include problems of affordability, limited research where market returns are small or uncertain (such as the 'neglected diseases' that predominantly affect the world's poorest), inefficient overlap of research efforts, and overuse of medicines such as antibiotics. The CEWG report called on WHO Member States to develop a global framework to improve monitoring, coordination and financing of R&D efforts through the establishment of a Global Health R&D Observatory and the negotiation of a binding treaty on R&D. While the treaty option has been put on the back-burner for several years, Member States nevertheless agreed at the 2013 World Health Assembly (WHA) on concrete steps towards a global framework. Progress at the 2013 WHA reaffirmed the central role of WHO as a convener, and the WHA's decision to create the Observatory within the WHO Secretariat underscored the organization's role as a source of strategic knowledge in the global health system. However, despite WHO's constitutional mandate as the 'directing and coordinating authority on international health work', in reality it faces major challenges in coordinating autonomous R&D actors such as states, firms and foundations in the global system. Strengthening its ability to do so requires, at a minimum, reforming its financing arrangements to provide it with a greater degree of independence from its largest donors. In addition, WHO may seem to be the natural arena for negotiating a binding R&D treaty, but negotiating new global agreements in other arenas such as the WTO, WIPO, or plurilateral fora offer the possibility of more enforceable and stronger public health norms. Nevertheless, no single arena in the existing system of global governance is perfectly suitable for the negotiation of progressive, inclusive, binding, enforceable, global health rules. While tradeoffs are inherent in the choice of any particular arena, leadership from either the multilateral institutions or influential governments can make a key difference in how beneficial any R&D treaty may be for health. In the coming years, global R&D debates will remain a critical issue to watch. The evolution of the global R&D system will be a harbinger not only of WHO's place in a rapidly-changing global health system, but also of our collective capacity to strengthen institutions of global governance for health.